Single Source Justification Over SAT Heart Valves.pdf

Attachment 7: Request for Sole Source Justification Format >SAT

VHAPG Part 806.3 OFOC Page 1 of 3 Revision: 01 Effective Date: 04/01/23

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C260-24-AP-0207 JOFOC Tracker #: FY24 - NCO 20 - 373

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 20 (NCO

20) procuring for the Portland VA Medical Center, utilizing purchase request 648-24-1-093- 0069.

2. Nature and/or Description of the Action Being Processed: This is a new requirement and is a firm-fixed-price purchase order requiring delivery within 45 days after receipt of order.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

The estimated value of the proposed action is $374,000.00. This procurement is for transcatheter heart valves (THV) to treat aortic stenosis. Aortic stenosis, the narrowing of the aortic valve opening, is one of the most common and most serious valve disease problems. Transcatheter aortic valve replacement (TAVR) is a less invasive procedure that does not require open heart surgery.

The quantities required on the shelf to perform cases for the patient population in VHAPOR as they are scheduled are as follows:

• 1 EA 20mm Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) with

Commander System

• 2 EA 23mm Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) with

Commander System

• 4 EA 26mm Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) with

Commander System

• 4 EA 29mm Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) with

Commander System

4. Statutory Authority Permitting Other than Full and Open Competition:

( ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

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Effective Date: 04/01/23

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4

(X) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR

6.302-5, VAAR 806.302-571(b)(1);

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition

Requires the Use of the Authority Cited Above (applicability of authority): Edwards Lifesciences is the only manufacturer of a balloon expandable transcatheter heart valve system in the United States. Furthermore, these types of medical devices are considered high-cost and high-quality and frequently referred to as physician preference items (PPIs).

The Medical Centers rely on expertise and judgement of their clinicians to prescribe the best devices they need for patient care and contracting cannot direct or influence their decision therefore, the devices outlined in this J&A fall under the applicable statutory authority and not available for FAR based competition.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: None.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The current prices for the 20mm, 23mm, 26mm, and 29mm Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) with Commander System are the same price as they were on Consignment Agreement 36C26018D0033 which expired on 8/5/2023. At the time of award the price was consider fair and reasonable.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Edwards Lifesciences LLC is the manufacturer of the SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) with Commander System and is the only one who can provide through a local Company Representative. These items are not available on an FSS or National Use Contract nor does it offer sales through a third party. These items are part of an FDA approved program.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

VAAR 806.302-571(b)(1) Prosthetic appliances and services. Contracting activities may procure prosthetic appliances and necessary services required in the fitting, supplying, and training and use of prosthetic appliances by purchase, manufacture, contract, or in such other manner as determined to be proper, without regard to any other provision of law. (38 U.S.C. 8123)

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Name of Proposed Contractor: Edwards Lifesciences Street Address: One Edwards Way City, State, Zip: Irvine, CA USA 92614 Phone: 949-250-2500

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Effective Date: 04/01/23

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: None.

12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Shaunessy Campbell Date Cardiology Procedure Lab Nurse Manager Portland VAMC

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Jacob Jackson Date Contracting Officer

NCO 20

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Krystal Weeks Date Branch Chief, WSNC & Prosthetics

NCO 20

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